Glossary
New product introduction (NPI)
What is a New Product Introduction?
New Product Introduction is a systematic process that enables medical device manufacturing companies to bring new products to the market efficiently and cost-effectively. NPI is a comprehensive process that covers the entire lifecycle of a new product, from idea generation to product launch, including:
- Research and development
- Formulation and manufacturing process development
- Clinical trials and regulatory submissions
- Scale-up and commercial manufacturing
- Packaging and labelling
- Quality control and assurance
What are the key steps in the NPI process?
The NPI process typically includes the following steps:
- Ideation: Establishing product objectives and specifications.
- Product Definition: Assessing the viability of the product concept
- Prototyping: Creating and refining prototypes
- Detailed Design: Ensuring prototypes meet desired outcomes and regulatory requirements
- Manufacturing: Scaling up production and preparing for market release
- Evaluation: Reviewing the NPI process for continuous improvement and compliance
How can companies ensure successful NPI?
To enhance the likelihood of a successful NPI, companies should:
- Foster cross-functional collaboration among teams involved in product development
- Implement robust project management practices to monitor progress and address issues promptly.
- Engage with experienced Contract Development Manufacturing Organizations (CDMOs) to leverage their expertise in NPI processes.
